FDA — authorised 23 September 2014
- Application: NDA206088
- Marketing authorisation holder: CELGENE CORP
- Local brand name: OTEZLA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Apremilast 30mg in United States
FDA authorised Apremilast 30mg on 23 September 2014 · 4 US adverse-event reports
Marketing authorisations
FDA — authorised 29 August 2025
- Application: NDA210745
- Marketing authorisation holder: AMGEN INC
- Local brand name: OTEZLA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 4
Most-reported reactions
- Suicide Attempt — 2 reports (50%)
- Depression — 1 report (25%)
- Hallucination — 1 report (25%)
Apremilast 30mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Apremilast 30mg approved in United States?
Yes. FDA authorised it on 23 September 2014; FDA authorised it on 29 August 2025; FDA has authorised it.
Who is the marketing authorisation holder for Apremilast 30mg in United States?
CELGENE CORP holds the US marketing authorisation.